| Primary Device ID | 00815588022128 |
| NIH Device Record Key | bf9dfb5d-5abb-4a06-9aed-f77883e63fd7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arjo Wiggins Medical, Inc. |
| Version Model Number | 101088AJW4040 |
| Catalog Number | 101088AJW4040 |
| Company DUNS | 182052670 |
| Company Name | STERIMED INC. |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815588022111 [Unit of Use] |
| GS1 | 00815588022128 [Primary] |
| FRG | Wrap, sterilization |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-09-21 |
| 00815588024771 | 88 54X72,50_CASE YB |
| 00815588024764 | 88 54X72,50_CASE Y |
| 00815588024757 | 88 54X54,100_CASE YB |
| 00815588024733 | 88 54X54,100_CASE Y |
| 00815588024719 | 88 54X54,100_CASE |
| 00815588024696 | 88 54X54,1600/CS-GAYLORD |
| 00815588024672 | 88 54X54,100_CASE |
| 00815588024658 | 88 48X48, 2000/CS-GAYLORD |
| 00815588024634 | 88 48X48,100_CASE WB |
| 00815588024610 | 88 48X48,100_CASE W |
| 00815588024597 | 88 48X48,100_CASE |
| 00815588024573 | 88 48X48,100_CASE |
| 00815588024559 | 88 45X45,100_CASE ZB |
| 00815588024542 | 88 45X45,100_CASE Z |
| 00815588024535 | 88 45X45,100_CASE |
| 00815588024528 | 88 45X45,100_CASE |
| 00815588024511 | 88 40X40, 3300/CS-GAYLORD |
| 00815588024481 | 88 40X40,3300/CS-GAYLORD |
| 00815588024474 | 88 40X40,100_CASE YB |
| 00815588024467 | 88 40X40,100_CASE Y |
| 00815588024450 | 88 40X40,100_CASE |
| 00815588024443 | 88 40X40,100_CASE |
| 00815588024436 | 88 36X36,150_CASE YB |
| 00815588024412 | 88 36X36,150_CASE Y |
| 00815588024399 | 88 36X36,150_CASE |
| 00815588024375 | 88 36X36,150_CASE |
| 00815588024351 | 88 32X32,6250/CS-GAYLORD |
| 00815588024344 | 88 32X32,250_CASE |
| 00815588024320 | 88 30X30,250_CASE XB |
| 00815588024313 | 88 30X30,250_CASE X |
| 00815588024306 | 88 30X30,250_CASE |
| 00815588024290 | 88 30X30 ,9000/ CS-GAYLORD |
| 00815588024276 | 88 30X30,250_CASE |
| 00815588024269 | 88 28X28,200_CASE XB |
| 00815588024252 | 88 28X28,200_CASE X |
| 00815588024245 | 88 24X24,500_CASE WB |
| 00815588024221 | 88 24X24,500_CASE W |
| 00815588024207 | 88 20X20,500_CASE VB |
| 00815588024191 | 88 20X20,500_CASE V |
| 00815588024184 | 88 18X18,500_CASE UB |
| 00815588024177 | 88 18X18,500_CASE U |
| 00815588024160 | 88 12X12,1000_CASE SB |
| 00815588024146 | 88 12X12,1000_CASE S |
| 00815588024122 | 77P 54X72,100_CASE Y |
| 00815588024108 | 77P 54X54,1800/CS-GAYLORD |
| 00815588024085 | 77P 54X54,100_CASE YB |
| 00815588024061 | 77P 54X54,100_CASE Y |
| 00815588024030 | 77P 48X48,2000/CS-GAYLORD |
| 00815588024023 | 77P 48X48,100_CASE W |
| 00815588024009 | 77P 45X45,250_CASE ZB |